FDA.reportPublic FDA data

zaleplon

Product NDC
50090-1564
11-digit product format
500901564
Labeler code
50090
Product ID
50090-1564_b6f10404-69b2-47b0-970e-bf392d4a6ebd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zaleplon
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078989
Marketing category
ANDA
Marketing start
2009-05-05
Substance
ZALEPLON
Active strength
10 mg/1
Pharmacologic classes
Central Nervous System Depression [PE], GABA A Agonists [MoA], gamma-Aminobutyric Acid A Receptor Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
zaleplon
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZALEPLON10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS62U433RMH
Rxcui313761

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
11ca9bc5-afb0-a2d5-938a-c2d33f89f4abProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1564-02023-02-07C16284748780-1f386c649-d09b-0266-e053-dadaa90a7c1aZaleplon Capsules USP
50090-1564-12023-02-07C16284748780-1f386c649-d09b-0266-e053-dadaa90a7c1aZaleplon Capsules USP
50090-1564-02023-01-30C16284748780-1f386c649-d09b-0266-e053-dadaa90a7c1aZaleplon Capsules USP
50090-1564-12023-01-30C16284748780-1f386c649-d09b-0266-e053-dadaa90a7c1aZaleplon Capsules USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1564-0zaleplon10 in 1 BOTTLECAPSULE1011
50090-1564-1zaleplon30 in 1 BOTTLECAPSULE3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1564-0EA - Each50090-156485f3dca9-0ef9-4788-923f-c75e8a9a073412018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1564ZALEPLON CAPSULE [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 2 package rows20240108_8276a418-6a4c-4b81-8170-2d3838576c6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313761zaleplon 10 MG Oral CapsulePSN8276a418-6a4c-4b81-8170-2d3838576c6d11
313761zaleplon 10 MG Oral CapsuleSCD8276a418-6a4c-4b81-8170-2d3838576c6d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1564-05009015640010 CAPSULE in 1 BOTTLE (50090-1564-0) 10 capsule2014-12-220000-00-00NoNoCurrent
50090-1564-15009015640130 CAPSULE in 1 BOTTLE (50090-1564-1) 30 capsule2014-12-22NoNoHistorical